Nuvasive CEO: FDA's Policies Could Cost Company $70 Million

On January 10, PricewaterhouseCoopers, the California Healthcare Institute, and BayBio released early results of the California Biomedical Industry 2012 Report, which surveyed biomedical industry CEOs.

Speaking at the announcement was a panel of three CEOs including Alex Lukianov, CEO of Nuvasive; Rick Winningham, CEO of Theravance; and Stephen Cary, PhD, CEO of Omniox.

When asked what the broader trends were in terms of FDA, Lukianov cited the much-talked about slow down in device approvals at the Center for Devices and Radiological Health's Office of Device Evaluation. Nuvasive, which is just over a decade old, has grown rapidly from a start up to a company with more than 1000 employees. "And I think the success we have enjoyed has been predicated upon innovation and the rapid release of new products," Lukianov says. "We have released, historically, about 10 new products per year over the last six years or so," he said. "That number last year was cut in half."

Lukianov explained that his firm continues to see ongoing challenges with regard to FDA and the release of products, citing moving regulatory goal posts and frequent requests for additional information. "From a broader perspective, there have been just really significant delays, to the point where last year, we estimated that the delays cost our company about $70 million in terms of last revenue in 2011 and pouring over into 2012," he said. He explained that the firm has been forced to reduce our headcount growth plans. "We didn’t have to make any cuts but we did have to reduce our headcount growth plans," he said. "And that is because of all of the products that were backed up at FDA."

(Part of) The Reason Behind the FDA Backlog

Lukianov said that FDA delays relative to product approvals are often unrelated to safety and efficacy. "For example, one of the products that we are trying to get approval for, which is a PMA product, has been on the market for six years in Europe with over 10,000 patients treated successfully," he said. "We’ve done a full PMA. We are in our second year of trying to get approval," he added. "And every time we turn around, it’s a moving goal post. Lukianov explains that the clinical study has been completed, and has been overseen by a string of people at FDA. "And the next evaluator comes in and says 'it would be interesting to look at this,' and 'it would be interesting to look at that,' and 'why don’t we run this out to x number of mechanical cycles?'

To address these issues, Nuvasive has has been involved with the ombudsmen and CDRH director Jeffrey Shuren, MD and has gotten some relief. "But still, what we want to see is transparency," he says. "And we want to make sure that there is not what is called 'clock manipulation' [of the agency's review times]," he said, explaining that "there are response times that FDA is subject to and "they manipulate the response times in many cases."

"If something changed relative to safety or efficacy, we would be the first to agree that we should make adjustments," Lukianov added, "Nobody is sitting here saying ‘we don’t care what the outcome is.’"